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NCT00200564 Clinical Trial

Ketamine and Postoperative Analgesia in Children

Postoperative Analgesia Clinical Trial

Official title:
Ketamine and Postoperative Analgesia in Children

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00200564
Other study ID # BRD/03/12-H
Secondary ID
Status Recruiting
Phase Phase 4
First received September 12, 2005
Last updated October 22, 2007
Start date February 2004

Study information
Verified date July 2005
Source Nantes University Hospital
Contact Véronique Bazin, MD
Phone 00 33 2 40 08 35 47
Email veronique.bazin@chu-nantes.fr
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

The benefit of small doses of ketamine has been demonstrated for postoperative analgesia in adults but remains unproved in children. The investigators' purpose is to evaluate the effects of continuous intravenous small doses of ketamine versus placebo to improve the quality of postoperative analgesia in children (6 months to 6 years of age). Caudal anesthesia is performed for intraoperative analgesia and all children receive paracetamol, a non-steroidal anti-inflammatory and continuous intravenous nalbuphine.

Recruitment information / eligibility
Status Recruiting
Enrollment 74
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 6 Months to 6 Years
Eligibility Inclusion Criteria:

- Children between 6 months to 6 years of age

- American Society of Anesthesiologists (ASA) I or II

- Undergoing elective surgery with intraoperative caudal analgesia

Exclusion Criteria:

- ASA III or IV

- Contraindication to caudal anesthesia

- Allergy to drugs used in the study

- Failure in caudal puncture

- Administration of morphine derivative

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind

Related Conditions & MeSH terms

Intervention

Drug:
• ketamine

Locations
Country Name City State
France Nantes University Hospital Nantes

Sponsors (1)
Lead Sponsor Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Area under the curve of pain scores (CHEOPS) measured every 2 hours during the first 24 hours after eyes open
Secondary Evaluation by the parents and nurses of the quality of analgesia with a visual analogue scale graded from 0 to 10 at the 24th hour
Secondary Number of painful episodes requiring additional boluses of nalbuphine
Secondary Number of children requiring morphine after inefficiency of additional boluses of nalbuphine
Secondary Percentage of children with side effects related to injection of ketamine
Secondary Time to complete feeding
Secondary Percentage of children with nausea or vomiting
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